RecruitingACTRN12619000742178

Controlled oxygen administration in term newborns and young infants requiring mechanical respiratory support and oxygen therapy

Effect of automated control of oxygen administration on oxygen saturation targeting in term newborns and young infants requiring mechanical respiratory support and oxygen therapy

Sponsor

Murdoch Childrens Research Institute

Enrollment

70 participants

Start Date

May 15, 2019

Study Type

Interventional

Conditions

Respiratory tract infection of infancy Neonatal hypoxic respiratory failure

Summary

The COATI study aims to study the impact of the VDL1.1 algorithm for automated control of inspired oxygen in term newborns and young infants with respiratory insufficiency requiring mechanical respiratory support (ventilation) and oxygen therapy. Time spent within the oxygen saturation target range will be compared during 12h periods of standard manual control and automated oxygen control (using the VDL1.1 algorithm which has been built into the SLE6000 ventilator as the OxyGenie setting) in random sequence. Comparison will also be made of time spent in hypoxic (too little oxygen) and hyperoxic (too much oxygen) ranges, frequency of hypoxic and hyperoxic episodes, overall oxygen requirement and frequency of manual FiO2 adjustments. The expected outcomes/hypothesis for this study are; That, under standard clinical conditions, the VDL1.1 oxygen control algorithm will be more effective in SpO2 targeting than manual control in the two study groups, with specifically: a) a higher proportion of time within target and alarm ranges b) a reduction of time in hypoxic and hyperoxic SpO2 ranges c) fewer hypoxic and hyperoxic episodes d) need for fewer manual FiO2 adjustments

Eligibility

Sex: Both males and femalesMax Age: 9 Monthss

Plain Language Summary

Simplified for easier understanding

Managing oxygen levels in sick newborns and young infants is one of the most delicate aspects of neonatal care. Too little oxygen (hypoxia) can damage organs, but too much (hyperoxia) can harm the eyes and lungs. Nurses and doctors currently adjust oxygen levels manually by reading monitors and tweaking a dial — but this is difficult to get right consistently, especially over many hours. The COATI study tests whether a computer algorithm called OxyGenie — built into the SLE6000 ventilator — can manage oxygen levels more accurately than manual adjustments. Two groups of babies are included: term newborns with breathing problems from conditions like respiratory distress syndrome or pulmonary hypertension, and younger infants with breathing difficulties caused by respiratory infections. Each baby will receive both manual and automated oxygen control for 12-hour periods (in random order), and the researchers will measure how much time is spent within the target oxygen range. Eligibility is open to newborns and young infants requiring breathing support and supplemental oxygen in a neonatal or paediatric intensive care unit. Babies with life-threatening instability or those expected to need a change in breathing support soon are excluded. If automated oxygen control proves superior, it could become standard practice in neonatal units around Australia.

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Interventions

Automated control of inspired oxygen therapy will be administered using a novel adaptive algorithm (VDL1.1), that has been embedded in a commercial ventilator (SLE6000) as the OxyGenie option. This device receives SpO2 input from an oximeter, compares the value with the midpoint of the desired SpO2 range, and provides an output, which is an updated value for FiO2. Automated oxygen control using the SLE6000 + OxyGenie will be compared with standard manual control in a crossover study of 24.5 hours duration. Time spent within the SpO2 target range will be compared during 12 hour periods of automated oxygen control (OxyGenie function on the SLE6000) and manual oxygen control, in random sequence, with a 30 minute washout period between the two epochs. The SpO2 target range will be 92-96% for both manual and automated control.There will be a 30 minute wash out period between interventions. A further 24.5 hour study could commence if the infant remains eligible, after a 30 minute washout. Comparison will also be made of time spent in hypoxic and hyperoxic SpO2 ranges, frequency of hypoxic and hyperoxic episodes, overall oxygen requirement and frequency of manual FiO2 adjustments. Adherence with automated control, and conversely, the use of the manual override option when in automated control, will also be assessed using the 1 Hz data log extracted from the SLE6000 ventilator.

Locations(1)

The Royal Childrens Hospital - Parkville

VIC, Australia

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ACTRN12619000742178